Subject: Cibinqo 5142-A SGM P2024

Drug

CIBINQO  (abrocitinib)

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          FDA-Approved Indication
          Indicated for the treatment of adults and pediatric patients 12 years of age and older with
          refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled
          with other systemic drug products, including biologics, or when use of those therapies is
          inadvisable.

          All other indications are considered experimental/investigational and not medically necessary.


     II.  DOCUMENTATION

          Submission of the following information is necessary to initiate the prior authorization review:
          A.  Initial requests:
               1.  Chart notes or medical records showing affected area(s) and affected body surface area
                    (where applicable).
               2.  Chart notes, medical record documentation, or claims history of prerequisite therapies
                    including response to therapy. If prerequisite therapies are not advisable, documentation
                    of why therapies are not advisable for the member.
         B.  Continuation requests: Documentation (e.g., chart notes) that the member has experienced
               a positive clinical response to therapy as evidenced by low disease activity or improvement
               in signs or symptoms of atopic dermatitis.


    III.  PRESCRIBER SPECIALTIES

          This medication must be prescribed by or in consultation with a dermatologist or
          allergist/immunologist.


    IV.  CRITERIA FOR INITIAL APPROVAL

          Atopic dermatitis
          A.  Authorization of 4 months may be granted for members 12 years of age or older for
               treatment of moderate-to-severe atopic dermatitis when the member has experienced an
               inadequate response or intolerance to at least one biologic (e.g., Dupixent, Adbry) or a
               targeted synthetic drug (e.g., Rinvoq) in the past year.

          B.  Authorization of 4 months may be granted for treatment of moderate-to-severe atopic
               dermatitis in members 12 years of age or older when all of the following criteria are met:
               1.  Affected body surface is greater than or equal to 10% body surface area OR crucial body
                    areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are
                    affected.
               2.  Member meets one of the following:
                    i.     Member has had an inadequate treatment response with one of the following in the
                           past year:
                           a.  A medium potency to super-high potency topical corticosteroid (see Appendix)
                           b.  A topical calcineurin inhibitor
                    ii.    The use of medium potency to super-high potency topical corticosteroid and topical
                           calcineurin inhibitor are not advisable for the member (e.g., due to contraindications,
                           prior intolerances).
               3.  Member has had an inadequate response to treatment with a systemic drug product
                    (e.g., oral cyclosporine, azathioprine, methotrexate, mycophenolate mofetil) indicated for
                    the treatment of atopic dermatitis, or use of these therapies are not advisable for the
                    member.


    V.  CONTINUATION OF THERAPY

          Atopic dermatitis
          Authorization of 12 months may be granted for members 12 years of age or older (including
          new members) who are using the requested medication for moderate-to-severe atopic
          dermatitis when the member has achieved or maintained a positive clinical response as
          evidenced by low disease activity (i.e., clear or almost clear skin), or improvement in signs and
          symptoms of atopic dermatitis (e.g., redness, itching, oozing/crusting).


   VI.  OTHER

          Member has had a documented negative tuberculosis (TB) test (which can include a
          tuberculosis skin test [TST] or an interferon-release assay [IGRA])* within 6 months of initiating
          therapy for persons who are naïve to biologic drugs or targeted synthetic drugs associated with
          an increased risk of TB.

          * If the screening testing for TB is positive, there must be further testing to confirm there is no
          active disease (e.g., chest x-ray). Do not administer the requested medication to members with
          active TB infection. If there is latent disease, TB treatment must be started before initiation of
          the requested medication.

          Member cannot use the requested medication concomitantly with any other biologic drug,
          targeted synthetic drug, or potent immunosuppressant such as azathioprine or cyclosporine.


  VII.  APPENDIX

         Table. Relative potency of select topical corticosteroid products

Potency	Drug	Dosage form	Strength
I. Super-high potency (group 1)	Augmented betamethasone dipropionate	Ointment, Lotion, Gel	0.05%
	Clobetasol propionate	Cream, Gel, Ointment, Solution, Cream   (emollient), Lotion, Shampoo, Foam, Spray	0.05%
	Fluocinonide	Cream	0.1%
	Flurandrenolide	Tape	4 mcg/cm2
	Halobetasol propionate	Cream, Lotion, Ointment, Foam	0.05%
II. High potency (group 2)	Amcinonide	Ointment	0.1%
	Augmented betamethasone dipropionate	Cream	0.05%
	Betamethasone dipropionate	Ointment	0.05%
	Clobetasol propionate	Cream	0.025%
	Desoximetasone	Cream, Ointment, Spray	0.25%
		Gel	0.05%
	Diflorasone diacetate	Ointment, Cream (emollient)	0.05%
	Fluocinonide	Cream, Ointment, Gel, Solution	0.05%
	Halcinonide	Cream, Ointment	0.1%
	Halobetasol propionate	Lotion	0.01%
III. High potency (group 3)	Amcinonide	Cream, Lotion	0.1%
	Betamethasone dipropionate	Cream, hydrophilic emollient	0.05%
	Betamethasone valerate	Ointment	0.1%
		Foam	0.12%
	Desoximetasone	Cream, Ointment	0.05%
	Diflorasone diacetate	Cream	0.05%
	Fluocinonide	Cream, aqueous emollient	0.05%
	Fluticasone propionate	Ointment	0.005%
	Mometasone furoate	Ointment	0.1%
	Triamcinolone acetonide	Cream, Ointment	0.5%
IV. Medium potency (group 4)	Betamethasone dipropionate	Spray	0.05%
	Clocortolone pivalate	Cream	0.1%
	Fluocinolone acetonide	Ointment	0.025%
	Flurandrenolide	Ointment	0.05%
	Hydrocortisone valerate	Ointment	0.2%
	Mometasone furoate	Cream, Lotion, Solution	0.1%
	Triamcinolone acetonide	Cream	0.1%
		Ointment	0.05% and 0.1%
		Aerosol Spray	0.2 mg per 2-second spray
V. Lower-mid potency (group 5)	Betamethasone dipropionate	Lotion	0.05%
	Betamethasone valerate	Cream	0.1%
	Desonide	Ointment, Gel	0.05%
	Fluocinolone acetonide	Cream	0.025%
	Flurandrenolide	Cream, Lotion	0.05%
	Fluticasone propionate	Cream, Lotion	0.05%
	Hydrocortisone butyrate	Cream, Lotion, Ointment, Solution	0.1%
	Hydrocortisone probutate	Cream	0.1%
	Hydrocortisone valerate	Cream	0.2%
	Prednicarbate	Cream (emollient), Ointment	0.1%
	Triamcinolone acetonide	Lotion	0.1%
		Ointment	0.025%
VI. Low potency (group 6)	Alclometasone dipropionate	Cream, Ointment	0.05%
	Betamethasone valerate	Lotion	0.1%
	Desonide	Cream, Lotion, Foam	0.05%
	Fluocinolone acetonide	Cream, Solution, Shampoo, Oil	0.01%
	Triamcinolone acetonide	Cream, lotion	0.025%
VII. Least potent (group 7)	Hydrocortisone (base, greater than or equal   to 2%)	Cream, Ointment, Solution	2.5%
		Lotion	2%
	Hydrocortisone (base, less than 2%)	Cream, Ointment, Gel, Lotion, Spray,   Solution	1%
		Cream, Ointment	0.5%
	Hydrocortisone acetate	Cream	2.5%
		Lotion	2%
		Cream	1%

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Cibinqo [package insert]. New York, NY: Pfizer Inc.; February 2023.
2. Simpson EL, Sinclair R, Forman S, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 clinical trial. Lancet. 2020;396:255-266.
3. Eichenfield LF, Tom WL, Chamlin SL, et. al. Guidelines of care for the management of atopic dermatitis: Section Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-51.
4. Eichenfield LF, Tom WL, Berger TG, et. al. Guidelines of care for the management of atopic dermatitis: Section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71:116-132.
5. Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on November 6, 2023 from: https://www.cdc.gov/tb/topic/testing/tbtesttypes.htm.
6. Topical Corticosteroids. Drug Facts and Comparisons.  Facts & Comparisons [database online]. St. Louis, MO:  Wolters Kluwer Health Inc; September 1, 2023.  Accessed November 2, 2023.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 11, 2024